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Completed

NCT Number: NCT00035165

EPO906 Therapy in Patients With Advanced Melanoma

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.

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Key information

Conditions

Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The following patients may be eligible for this study:

  • Patients with advanced metastatic melanoma defined as poor prognosis Stage III melanoma and Stage IV disease, which has been histologically or cytologically confirmed with at least one measurable lesion not including bone metastases (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
  • Patients with poor prognosis Stage III melanoma must have locally advanced unresectable disease that is measurable (repeat histological or cytological confirmation is not necessary at the time of study entry if previous results are available and there is no question in the investigator's opinion as to the diagnosis)
  • Must have a life expectancy of greater than three (3) months
  • Prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but must have been completed > 4 weeks prior to treatment
  • Prior vaccine therapy is permitted, but must have been completed > 4 weeks prior to treatment
  • Patient has no major impairment of hematological function (red blood cell transfusions and repeat evaluations for study entry are allowed).

Exclusion criteria

The following patients are not eligible for this study:

  • Patients with choroidal ocular melanoma
  • Patients with symptomatic CNS metastases or leptomeningeal involvement
  • Patients with renal or hepatic dysfunction
  • Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
  • Patients with severe cardiac insufficiency
  • Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
  • Patients who have received any investigational compound or anti-melanoma vaccine within the past 28 days or those who are planning to receive other investigational drugs while participating in the study
  • Patients who had received radiotherapy within the last 4 weeks to a site which will be the reference for disease assessment (however, new or progressive lesions in the previously irradiated fields of these patients may be used for disease assessment and patients must have recovered from the side effects of radiotherapy)
  • Patients receiving chemotherapy within the last four weeks
  • History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
  • Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
  • HIV+ patients
  • Pregnant or lactating females.

Treatment and study plan

epothilone b

Drug

intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off

Other names: Patupilone, EPO906

Primary outcomes

  1. Tumor response (complete response (CR), partial response (PR), stable disease (SD))

    Time frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)

    Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.

Secondary outcomes

  1. Number and percentage of patients with Adverse events

    Time frame: as necessary

    Safety and tolerabilty of EPO906: Safety assessments consisted of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance status.

  2. Objective response rate (ORR)

    Time frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)

  3. Time to disease progression (TTP)

    Time frame: at screening, at least every eight weeks (one week following the last dose of EPO906 in every even-numbered cycle)

  4. Overall Survival (OS)

    Time frame: from the date of the first dose of treatment to date of death from any cause, or the last date the patient is known to be alive

  5. Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma

    Time frame: prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment

    For biomarker development

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Melanoma

Important dates

Study start
2002
Primary completion
2003
First posted
May 3, 2002
Registry last updated
Apr 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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